Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316706
First received: April 19, 2006
Last updated: September 13, 2012
Last verified: September 2012
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cervical Intraepithelial Neoplasia
Papillomavirus Infection
Interventions: Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Biological: Havrix™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects from the Cervarix group continued the long-term follow-up study until Month 48 while subjects from the Havrix group completed the study at Month 24.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.

Participant Flow:   Overall Study
    Cervarix Group     Havrix Group  
STARTED     626     619  
COMPLETED     588 [1]   571 [2]
NOT COMPLETED     38     48  
Lost to Follow-up                 38                 48  
[1] Subjects in Cervarix group that completed the study at Month 48
[2] Subjects in Havrix group that completed the study at Month 24



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Total Total of all reporting groups

Baseline Measures
    Cervarix Group     Havrix Group     Total  
Number of Participants  
[units: participants]
  626     619     1245  
Age  
[units: years]
Mean ± Standard Deviation
  12.1  ± 1.4     12.1  ± 1.4     12.1  ± 1.4  
Gender  
[units: participants]
     
Female     626     619     1245  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At 18, 24, 36 and 48 months ]

2.  Secondary:   Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up   [ Time Frame: At Months 18 and 24 ]

3.  Secondary:   Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up   [ Time Frame: At Month 36 and 48 ]

4.  Secondary:   Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up   [ Time Frame: From Month 18 to Month 24 ]

5.  Secondary:   Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up   [ Time Frame: From Month 24 to Month 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00316706     History of Changes
Other Study ID Numbers: 104896 (month 18 FU), 104902, 104904, 104918
Study First Received: April 19, 2006
Results First Received: November 12, 2009
Last Updated: September 13, 2012
Health Authority: Germany: Land Authority for Health and Social Issues
Taiwan: Department of Health
United States: Food and Drug Administration